TIDMTSP

RNS Number : 8541P

TruSpine Technologies PLC

12 October 2023

12 October 2023

TruSpine Technologies plc

("TruSpine" or the "Company")

Further re: FDA Update

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering "screwless," spinal (vertebral) stabilisation systems announces that, further to the announcement on 3 October 2023, the Company has submitted additional documentation and provided further clarification in regard to the questions raised by the U.S. Food and Drug Administration ("FDA") relating to the Company's FDA 510(k) application.

TruSpine CEO Laurence Strauss commented: "We are pleased the US FDA have responded promptly regarding our 510(k) application for Cervi-LOK. Our board have sought to clarify the matters raised and responded promptly with the required documentation. The Board believes the information provided should assist the FDA and help them to complete their technical review. I look forward to reporting back with further progress."

This announcement contains inside information for the purposes of the UK Market Abuse Regulation, and the Directors of the Company are responsible for the release of this announcement.

Enquiries:

 
 TruSpine Technologies Plc                                   Tel: +44 (0)20 7118 0852 
 Laurence Strauss, Chief Executive Officer 
 
 Cairn Financial Advisers LLP (AQSE Corporate Adviser)       Tel: +44 (0)20 7213 0880 
 Liam Murray / Ludovico Lazzaretti 
 Peterhouse Capital Limited (Broker & Financial Adviser) 
                                                             Tel: +44 (0)20 7469 0930 
 Lucy Williams / Duncan Vasey 
 Novus Communications (PR and IR)                            Tel: +44 (0)20 7448 9839 
 Alan Green / Jacqueline Briscoe                              novuscomms@truspine.org

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identi ed by their use of terms and phrases such as "believe", "could", "should" "envisage", "estimate", "intend", "may", "plan", "potentially", "expect", "will" or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements re ect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.

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October 12, 2023 02:00 ET (06:00 GMT)

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